N/A
Completed N=6
Pathologic and Immunologic Response After Ablative Radiation in Lung Cancer
Non-small Cell Lung Cancer Stage I
Source: ClinicalTrials.gov NCT03603002 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Examine the T-cell Receptor Profile Changes Induced in the Tumor After SABR
Summary
This is a pilot study to compare pre- and post-SABR core biopsies of stage I NSCLC tumors to identify SABR-induced immune-mediated tumor recognition based on a significant and specific expansion of T-cell clones using a novel T-cell receptor (TCR) sequencing assay. This will be coupled with (1) novel genomic analysis of candidate tumor antigens that may be released from the pre-SABR tumor and (2) functional validation assays to screen post-treatment peripheral blood T-cells for reactivity to these released candidate tumor antigens. In addition, cell-based analysis will be used to identify changes in key T-cell infiltrates into the post-SABR tumor.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Examine the T-cell Receptor Profile Changes Induced in the Tumor After SABR |
— | — |
| SECONDARY Evaluate Candidate Tumor Antigens Released From the Tumor by SABR |
— | — |
| SECONDARY Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes in the Tumor After SABR. |
0; 0; 0; NA; NA; 1 | — |
| SECONDARY Detection of Peripheral Neoantigen-specific T-cell Responses and Dynamics After SABR. |
2 | — |
| SECONDARY Dual-energy (DE) CT Imaging Characteristics After SABR |
— | — |
| SECONDARY Number of Participants With Grade 2+ Toxicity Events |
— | — |
| SECONDARY Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR. |
4; 2; 3; 4; NA; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Age > 18 year
- Confirmed non-small cell lung cancer after initial biopsies
- Patient with accessible tumor for biopsy
- Patient is to have sufficient initial core biopsy samples for tissue analyses
- Stage I lung cancer
- Adequate normal organ and marrow function
- Patient with tumor amenable to SABR treatment as determined by a radiation oncologist
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
Exclusion Criteria
- Primary tumors not amenable to serial core biopsies.
- Prior thoracic radiation in the region that will be treated by SABR.
- Patient may not be receiving any other concurrent investigational agents or chemotherapy.
- Patient may not be receiving or received immunotherapy.
- Patients may not be on or use steroids within 14 days before radiation, and from the duration of radiation to the time of the post-SABR biopsies and blood samples.
- Female patients who are pregnant from screening to completion of SABR
Data sourced from ClinicalTrials.gov (NCT03603002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.